The benefits of computerized forms as compared to paper forms are numerous. Data entry is easier and faster, paper costs are reduced, storage space is optimized, retrieval is faster, and data integrity is ensured. Moreover, because of the use of database and spreadsheet technology, reports concerning data entered on the forms can be generated much faster and even automatically. Configuration control is also made easier. Finally, when a computer network is used, data entry can be monitored in real time and multiple users can access a given form and its data simultaneously.
In contrast, when paper forms are used, data entry is slow, the paper version of the form plus the required copies take up an inordinate amount of storage space, and retrieval of paper forms requires a manual filing system. Report generation involves manually going through a number of completed forms to extract the required data. Finally, a manual configuration control system must be implemented.
Computerized forms overcome these and many other disadvantages of paper forms. Still, computerized forms do suffer from some shortcomings. For example, computers typically handle data entry changes by completely eliminating the old values and replacing them with the most current values. For example, if the value of 25 is typed into a field of a spreadsheet or database and then this value is replaced by the value 26, there will be no record of the old value 25 using current electronic form generation products.
This deficiency in computerized databases and spreadsheets has severely affected the implementation of computerized forms in some industries. For example, the Food and Drug Administration (FDA) has issued regulations which require pharmaceutical companies and other companies regulated by the FDA to cross out an incorrect data entry so that it can still be read and also require data entry personnel to initial or sign in association with the change. Similar rules apply in many diverse industries, including data recording requirements for military testing and inspection procedures and medical patient records. The reason for these cross out and initial or sign procedures is to provide a clear audit trail for evaluation purposes should a drug, military device, or medical procedure fail to perform as specified or worse, harm individuals or groups of individuals.
As delineated above, currently known computerized paperless form generation systems cannot implement this cross out and initial requirement because, by their very nature, computers allow changes to be made to data without keeping a record of the data changes. Indeed, one of the advantages of computerized data entry is the ease of making changes. Another problem with computerized forms is the unusual ease with which unauthorized modifications can be made. Since all of the data, the form itself, and even any electronic or digital biometric signatures associated with the form are really just stored computer records, unauthorized access to these records can be made despite security algorithms and changes or modifications can be made severely affecting the integrity of the data. For example, pharmaceutical company personnel facing an investigation and/or a lawsuit, may retrieve old records and improperly change certain data entries to escape culpability and/or liability.
Accordingly, the change from paper based forms to computerized forms has not been implemented in some industries as quickly as desired and one regulatory agency, namely the FDA, closely scrutinizes any attempt to computerize the standard operating procedures ("SOP") batch form used by pharmaceutical companies to keep a record of pharmaceutical manufacturing processes.